Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 23, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled "Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
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